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GENESIS32™ makes it easy to create applications that comply with the latest FDA regulations.
Audit trails, enforced logins and restricted security access are integrated into every GENESIS32™
software system.
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Industries Served
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Benefits
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For systems requiring FDA oversight, the following industries are benefiting from ICONICS' solutions:
Drug and Pharmaceutical
Food and Beverage
Medical Device Manufacturing
Blood Handling
Cosmetics
And Many More...
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Customers who are deploying GENESIS32™ in an FDA 21 CFR 11 application will enjoy these benefits:
Maximum security with integrated popular biometrics
Operational accountability through sequence checking
Accurate audit trail information of who did it what, when, where, and why
Applications that are designed for the FDA 21 CFR Part 11 regulation
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Designed for FDA 21 CFR 11 Compliance and Accountability
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The Food and Drug Administration has recently started enforcing the rules of compliance
as outlined in the FDA 21 CFR 11 (Code of Federal Regulations: Food and Drug Administration
Title 21, Chapter I, Part 11) - "Electronic Records; Electronic Signatures." GENESIS32™
offers many features that will help you build a system that complies with FDA 21 CFR 11.
It enables proper handling and recording of FDA-regulated electronic information and applies
"electronic signatures" such that the FDA considers them to be "equivalent" to that of
handwritten signatures and documents.
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Secure Audit Trails Track Operator Input and Control Changes
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Using the GenEvent™ Server, a standard part of GENESIS32™, keeping track of operator
input changes is automatic. This tracking system records the date and time stamp along
with the name of the person performing the action, as well as the value entered and the
tag name being affected. In addition, GENESIS32™ also captures the node name, thus
recording information pertaining to who, what, when and where.
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Click on the images to enlarge
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One Software System Reduces Development Time
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Create applications with one common development studio and deploy them to popular Microsoft®
Windows® operating systems such as Windows® 98, ME, 2000, 2000 Server, XP and Windows NT®.
Deploy applications to Web browsers such as Microsoft® Internet Explorer and Terminal Servers
as well as dedicated wireless Pocket PCs, Windows® CE, Embedded NT and Embedded XP devices.
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Record and Report Operator Comments
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Create applications with one common development studio and deploy them to popular Microsoft®
Windows® operating systems such as Windows 98, ME, 2000, 2000 Server, XP and Windows® NT.
Deploy applications to Web browsers such as Microsoft Internet Explorer and Terminal Servers
as well as dedicated wireless Pocket PCs, Windows® CE, Embedded NT and Embedded XP devices.
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Record and Report Operator Comments
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Both the AlarmWorX™32 Logger and the TrendWorX™32 Logger record their information to industry
standard databases, including Microsoft® SQL Server, MSDE, Microsoft Access and Oracle®.
Using such standard corporate databases provides long-term maintenance, reporting and
retrieval throughout the retention period.
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Create Operational Sequence Checking for Operators
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For applications that require operational system checks to enforce permitted sequencing of
steps and events, GraphWorX™32 (the visualization component of GENESIS32) is ready to help.
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Configuration and Runtime Password Revision, Control and More
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The GENESIS32™ suite of applications offers many standard features. From password revision
controls to timeout enforcement, from document revision control to unauthorized access
detection and prevention, ICONICS' products are ready to assist in the overall management
and accountability of today's pharmaceutical industry related to meeting FDA 21 CFR 11
regulations.
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Integrated Security Enforces Logins and Restricts Access with Biometrics
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The GENESIS32™ suite offers a powerful Security Server component designed to restrict
user access rights to various parts of the system. Not only are certain files and/or
applications restricted, but specific features within each module may also be restricted
on a per-user basis. Central to the FDA 21 CFR 11 is the absolute confirmation of users'
unique IDs and the association of these with each employee's actions. GENESIS32™ seamlessly
integrates Biometric mice, hand, face and eye recognition as well as other Biometric
technologies, providing the most comprehensive identification system available.
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International Language Switching Technology
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Companies needing to deploy their reports and documents anywhere in the world can now
define multiple languages with automatic engineering units conversion.
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Traceable Alarm and Event History
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Record operator set-point and control changes using the GenEvent™ Server component.
The GenEvent Server also creates a traceable history of other "system events." Include
important items such as startup/shutdown sequences and times, operator login events,
security issues, trouble reports, and much more.
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Learn More ...
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